Lutrate Depot leuprolide acetate Kit — NDC 83831-134-01 (Billing 83831-0134-01)
This is a package of Lutrate Depot leuprolide acetate Kit from Avyxa Pharma, LLC, marketed since Mar 2025 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 83831-134-01 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 83831 labeler · 134 product · 01 package
- Package marketed since
- Mar 26, 2025
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 8383113401 5
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 044965
- GCN: 84594
- GPI-14 (Medi-Span): 21405010152230
- HICL (First Databank): 021102
- AHFS class code: 10:00.00.00
- RxCUI (RxNorm): 2606516
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Gonadotropin Releasing Hormone Receptor Agonist class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Leuprolide injection is used to treat certain types of prostate cancer central precocious puberty (CPP; a condition causing children to enter puberty too soon, resulting in faster than normal bone growth and development of sexual characteristics) endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body and causes infertility, pain before and during menstrual periods, pain during and after sexual activity, and heavy, irregular bleeding) anemia (a lower-than-normal number of red blood cells) caused by uterine fibroids (growths i...
Read the full MedlinePlus article ↗- That's a really common concern, and it's smart to ask. When you first start leuprolide, your testosterone levels actually spike for a week or two before the drug kicks in and bring...
- Why does my doctor say my symptoms might get worse right after starting leuprolide?
- Hot flashes are actually one of the most common side effects in men taking leuprolide — over half of men in clinical studies experienced them. Because leuprolide drops testosterone...
- Will I get hot flashes? I thought that was just a women's issue.
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $2,001.13 | — |
| Medicare Part B allowsASP · J1954 | $687.287 / J1954 unit | — |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 5, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Billing & reimbursement
Where does this data come from?
- CMS ASP NDC-HCPCS crosswalk · refreshed Sep 22, 2026
- DMEPDAC NDC-HCPCS crosswalk
- openFDA NSDE billing units · refreshed Sep 7, 2026
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 83831-0134-01 You're viewing this Main listing | 1 KIT in 1 CARTON * 2 mL in 1 VIAL, SINGLE-DOSE * 2 mL in 1 SYRINGE | 2025-03-26 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Leuprolide Acetate 00781-4003-32 | Sandoz | 1 kit | $197.606 | AP | Availability likely | — |
| Leuprolide Acetate 55150-0478-01 | Eugia | 1 kit | $197.606 | AP | Availability likely | — |
| leuprolide acetate 47335-0936-40 | Sun | 1 kit | $197.606 | AP | Availability likely | — |
| Leuprolide Acetate 70710-1769-03 | Zydus | 1 kit | $197.606 | AP | Availability likely | — |
| Leuprolide Acetate 72664-0611-28 | VGYAAN | 1 kit | $261.318 | AP | FDA listed | — |
| Lupron Depot 00074-3641-03 | AbbVie | 1 kit | $1,822.080 | — | Availability likely | — |
| Lupron Depot 00074-3642-03 | AbbVie | 1 kit | $2,174.170 | — | Availability likely | — |
| Lupron Depot 00074-3663-03 | AbbVie | 1 kit | $5,437.400 | — | Availability likely | — |
| Lupron Depot 00074-3346-03 | AbbVie | 1 kit | $6,516.300 | — | Availability likely | — |
| Leuprolide Acetate Depot 69097-0909-50 | CIPLA | 1 kit | — | — | FDA listed | — |
| Lutrate Depotthis 83831-0134-01 | Avyxa | 1 kit | — | — | FDA listed | — |
| Fensolvi 62935-0153-50 | TOLMAR | 1 kit | — | — | FDA listed | — |
| Lupron Depot 00074-3473-03 | AbbVie | 1 kit | — | — | FDA listed | — |
| Lupron Depot-PED 00074-9694-03 | AbbVie | 1 kit | — | — | FDA listed | — |
| Lupron Depot-PED 00074-2108-03 | AbbVie | 1 kit | — | — | FDA listed | — |
| Lupron Depot-PED 00074-2440-03 | AbbVie | 1 kit | — | — | FDA listed | — |
| Lupron Depot 00074-3683-03 | AbbVie | 1 kit | — | — | FDA listed | — |
| Lupron Depot-PED 00074-3575-01 | AbbVie | 1 kit | — | — | FDA listed | — |
| Leuprolide Acetate 70771-1687-03 | Zydus | 1 kit | — | AP | FDA listed | — |
| Lupron Depot-PED 00074-2282-03 | AbbVie | 1 kit | — | — | FDA listed | — |
| Lupron Depot-PED 00074-3779-03 | AbbVie | 1 kit | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Leuprolide inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Avyxa Pharma, LLC labeler code 83831
- Frindovyx Cyclophosphamide 1 g/2mL Injection NDC 83831-120-02
- Frindovyx Cyclophosphamide 2 g/4mL Injection NDC 83831-121-04
- AVGEMSI Gemcitabine 38 mg/mL Injection, Solution NDC 83831-123-01
- AVGEMSI Gemcitabine 38 mg/mL Injection, Solution NDC 83831-124-01
- AXTLE pemetrexed 100 mg/4mL Injection, Powder, Lyophilized, For Solution NDC 83831-131-01
- AXTLE pemetrexed 500 mg/20mL Injection, Powder, Lyophilized, For Solution NDC 83831-132-01
- KYXATA CARBOplatin 80 mg/8mL Injection NDC 83831-141-08
- KYXATA CARBOplatin 500 mg/50mL Injection NDC 83831-142-50
- FAVLYXA Fluorouracil 25 mg/mL Injection, Solution NDC 83831-143-01
- Avopef etoposide 100 mg/5mL Injection NDC 83831-144-05
- Avopef etoposide 500 mg/25mL Injection NDC 83831-145-25
- VYKOURA leucovorin calcium 50 mg/5mL Injection NDC 83831-147-05
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE LUTRATE DEPOT 22.5 mg for 3-month administration (leuprolide acetate) is indicated for treatment of advanced prostate cancer. LUTRATE DEPOT is a gonadotropin-releasing hormone (GnRH) agonist indicated for: Treatment of advanced prostate cancer. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Due to different release characteristics, the dosage strengths are not additive and must be selected based upon the desired dosing schedule ( 2 ). LUTRATE DEPOT 22.5 mg for 3 months administration, given as a single intramuscular injection every 12 weeks. ( 2.1 )
2.1LUTRATE DEPOT 22.5 mg for 3-Month Administration LUTRATE DEPOT must be administered under the supervision of a physician. In patients treated with GnRH analogues for prostate cancer, treatment is usually continued upon development of metastatic castration-resistant prostate cancer. Table 1.
LUTRATE DEPOT Recommended Dosing Dosage 22.5 mg for 3-Month Administration Recommended Dose 1 injection every 12 weeks The recommended dose of LUTRATE DEPOT 22.5 mg for 3-month administration is one injection every 12 weeks. Do not use concurrently a fractional dose, or a combination of doses of this or any depot formulation due to different release characteristics. Incorporated in a depot formulation, the lyophilized microspheres must be reconstituted and administered every 12 weeks as a single intramuscular injection.
2.2Reconstitution Instructions for LUTRATE DEPOT Reconstitute and administer the lyophilized microspheres as a single intramuscular injection. The suspension should be administered immediately after reconstitution. As with other drugs administered by intramuscular injection, the injection site should be alternated periodically.
Visually inspect LUTRATE DEPOT powder (white to off-white powder). DO NOT USE the vial if clumping or caking is evident. A thin layer of powder on the wall of the vial is considered normal prior to mixing with the diluent.
The diluent contained in the prefilled syringe should appear clear and colorless. Use ONLY the provided diluent for reconstitution of LUTRATE DEPOT. DO NOT use other diluents.
The reconstituted product is a suspension of milky, white color appearance. LUTRATE DEPOT is packaged in a commercial kit. Each kit contains: One vial containing 22.5 mg of leuprolide acetate as lyophilized microspheres.
One prefilled syringe containing 2 mL of mannitol for injection. One MIXJECT transfer device including one needle. Please read the instructions completely before you begin.
MIXJECT Preparation Wash your hands with soap and hot water and put on gloves 1 immediately prior to preparing the injection. Place the tray on a clean, flat surface that is covered with a sterile pad or cloth. Remove the MIXJECT device, the backstop, the prefilled syringe containing the solvent for reconstitution and the LUTRATE DEPOT vial.
Remove the Flip-Off button from the top of the vial, revealing the rubber stopper. Place the vial in a standing upright position on the prepared surface. Disinfect the rubber stopper with the alcohol wipe.
Discard the alcohol wipe and allow the stopper to dry. Insert the backstop to the flange of the syringe until you feel it snap in place . Proceed to MIXJECT Activation.
MIXJECT Activation Peel the cover away from the blister pack containing the vial adapter (MIXJECT). Do not remove the vial adapter from the blister pack. Place the blister pack containing the vial adapter firmly on the vial top, piercing the vial.
Push down gently until you feel it snap in place. Remove the cap from the syringe barrel and then, remove the blister pack from the vial adapter . Connect the syringe to the vial adapter by screwing it clockwise into the opening on the side of the vial adapter.
Be sure to gently twist the syringe until it stops turning to ensure a tight connection. While holding the vial, place your thumb on the plunger rod and push the plunger rod in all the way to transfer the diluent from the pre-filled syringe into the vial. Do not release the plunger rod.
Keeping the plunger rod depressed, gently swirl the vial for approximately one minute until a uniform milky-white suspension is obtained . This will ensure complete mixing of LUTRATE DEPOT and the sterile mannitol solution diluent. The suspensio… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS LUTRATE DEPOT For Injection: 22.5 mg of leuprolide acetate for 3-month administration as lyophilized microspheres in a single dose vial as a kit with a prefilled syringe containing 2mL 0.8% mannitol solution and a MIXJECT transfer device for a single dose injection. For Injection: 22.5 mg of leuprolide acetate in a single dose vial as a kit with a prefilled syringe containing diluent and a MIXJECT transfer device. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS LUTRATE DEPOT is contraindicated in: Hypersensitivity LUTRATE DEPOT is contraindicated in individuals with known hypersensitivity to GnRH agonists or any of the excipients in LUTRATE DEPOT. Reports of anaphylactic reactions to GnRH agonists have been reported in the medical literature. Hypersensitivity to GnRH, GnRH agonist or any of the excipients in LUTRATE DEPOT. ( 4 ).
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Tumor Flare: Increased serum testosterone (~50% above baseline) during first week of treatment; monitor serum testosterone and PSA. ( 5.7 ) Transient worsening of symptoms, or additional signs and symptoms of prostate cancer during the first few weeks of treatment. ( 5.1 ) Patients may experience a temporary increase in bone pain which can be managed symptomatically.
( 5.1 ) Ureteral obstruction and spinal cord compression have been reported with GnRH agonists, which may contribute to paralysis with or without fatal complications. ( 5.1 ) Metabolic Syndrome: The use of GnRH agonists may lead to an increased risk of metabolic changes such as hyperglycemia, diabetes, hyperlipidemia, and non-alcoholic fatty liver disease. Monitor for signs and symptoms of metabolic syndrome including lipids, blood glucose level and/or HbA1c and manage according to current treatment guidelines.
( 5.2 ) Cardiovascular Diseases: Increased risk of myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH analogs in men. Monitor for cardiovascular disease and manage according to current clinical practice. ( 5.3 ) Effect on QT/QTc Interval: Androgen deprivation therapy may prolong QT interval.
Consider risks and benefits. ( 5.4 ) Convulsions have been observed in patients with or without a history of predisposing factors. Manage convulsions according to the current clinical practice.
( 5.5 ) Severe Cutaneous Adverse Reactions (SCARs), including Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), may occur in patients treated with LUTRATE DEPOT. Interrupt LUTRATE DEPOT if signs or symptoms of SCARs develop. Permanently discontinue if SCARs are confirmed.
( 5.6 ) Monitor serum levels of testosterone following injection of LUTRATE DEPOT 22.5 mg for 3-month administration. ( 5.7 ) Embryo-Fetal Toxicity: LUTRATE DEPOT may cause fetal harm. ( 5.8 , 8.1 )
5.1Tumor Flare Initially, LUTRATE DEPOT, like other GnRH agonists, causes increases in serum levels of testosterone to approximately 50% above baseline during the first weeks of treatment. Ureteral obstruction and spinal cord compression have been observed, which may contribute to paralysis with or without fatal complications. Transient worsening of symptoms may develop.
Patients may experience a temporary increase in bone pain, which can be managed symptomatically. Patients with metastatic vertebral lesions and/or with urinary tract obstruction should be closely observed during the first few weeks of therapy.
5.2Metabolic Syndrome The use of GnRH agonists may lead to metabolic changes such as hyperglycemia, diabetes mellitus, and hyperlipidemia. Non-alcoholic fatty liver disease, including cirrhosis, occurred in the post-marketing setting. Hyperglycemia may represent new-onset diabetes mellitus or worsening of glycemic control in patients with pre-existing diabetes.
Monitor for changes in serum lipids, blood glucose and/or glycosylated hemoglobin (HbA1c) in patients receiving a GnRH agonist, and manage according to current treatment guidelines.
5.3Cardiovascular Diseases Increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH agonists in men. The risk appears low based on the reported odds ratios, and should be evaluated carefully along with cardiovascular risk factors when determining a treatment for patients with prostate cancer. Patients receiving a GnRH agonist should be monitored for symptoms and signs suggestive of development of cardiovascular disease and be managed according to current clinical practice.
5.4Effect on QT/QTc Interval Androgen deprivation therapy may prolong the QT/QTc interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, and in patients taking drugs k… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following is discussed in more detail in other sections of the labeling: Tumor Flare [see Warnings and Precautions (5.1) ] Metabolic Syndrome [ see Warnings and Precautions (5.2) ] Cardiovascular Disease [see Warnings and Precautions (5.3) ] Effect on QT/QTc Interval [ see Warnings and Precautions (5 .4) ] Convulsions [see Warnings and Precautions (5.5) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.6) ] Most common adverse reactions (incidence > 10%) are hot flushes, upper respiratory infection, fatigue, diarrhea, pollakiuria, arthralgia, and injection site pain ( 6 ) .
As with other GnRH agonist, other adverse reactions, including decreased bone density and rare cases of pituitary apoplexy may occur. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Avyxa Pharma, LLC at 1-888-520-0954 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. LUTRATE DEPOT 22.5 mg for 3-Month Administration In a clinical trial of LUTRATE DEPOT 22.5 mg for 3-month administration, patients were treated for 24 weeks with 157/163 receiving two injections. The table includes adverse reactions were reported in 5% or more of the patients during the treatment period as well as the incidence of these adverse reaction that were considered, by the treating physician, to be at least possibly related to LUTRATE DEPOT.
Grade 3-4 adverse reactions reported as treatment-emergent in 13% of patients and treatment-related 4% of patients. CTCAE v.3 1 Includes cold sweat, flushing, hot flush, hyperhidrosis, and night sweats 2 Includes influenza, influenza-like illness, nasal congestion, nasopharyngitis, rhinorrhea, upper respiratory tract infection and congestion Table 2. Adverse Reactions Reported in ≥ 5% of Patients LUTRATE DEPOT 22.5 mg for 3-Month Administration N = 163 (%) Grade 1-4 Treatment-Emergent Treatment-Related Hot Flush/Flushing 1 128 (79) 127 (78) Upper Respiratory Infection 2 28 (17) 0 Fatigue/Asthenia 24 (15) 22 (13) Diarrhea 21 (13) 2 (1) Pollakiuria 20 (12) 3 (2) Arthralgia/Arthritis 18 (11) 2 (1) Injection Site Pain/Discomfort 18 (11) 15 (9) Constipation 15 (9) 1 (0.6) Extremity Pain 14 (9) 0 Nausea 14 (9) 4 (2) Nocturia 14 (9) 3 (2) Abdominal Pain/Discomfort 13 (8) 1 (0.6) Urinary Tract Pain 13 (8) 2 (1) Dizziness 12 (7) 2 (1) Headache/Sinus Headache 12 (7) 1 (0.6) Urinary Tract Infection 12 (7) 0 Bone Pain 11 (7) 4 (2) Back Pain 10 (6) 1 (0.6) Hypertension/Blood Pressure Increased 10 (6) 0 Pruritus/Generalized Pruritus 9 (6) 3 (2) In the same study, erectile dysfunction and testicular atrophy were reported in patients on LUTRATE DEPOT 22.5 mg.
Laboratory abnormalities During the treatment period, at least a one grade change in laboratory values was seen (>10%) in the following: anemia, increased triglyceride, hyperglycemia, increased cholesterol, increased creatine kinase, leukopenia, increased AST, increased creatinine, and increased ALT.
6.2Post-marketing Experience The following adverse reactions have been identified during post approval use of gonadotropin-releasing hormone agonists. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Mood swings, including depression, have been reported.
There have been very rare reports of suicidal ideation and attempt. Many, but not all, of these patients had a history of depression or other psychiatric illness. Patients should be counseled on the possibility of development or worsening of depression during treatment with LUTRATE DEPOT.
Symptoms consistent with an anaphylactoid or asthmatic process have been rarely (incide… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS No pharmacokinetic-based drug-drug interaction studies have been conducted with LUTRATE DEPOT.
7.1Drug/Laboratory Test Interactions Administration of LUTRATE DEPOT in therapeutic doses results in suppression of the pituitary-gonadal system. Normal function is usually restored within three months after treatment is discontinued. Due to the suppression of the pituitary-gonadal system by LUTRATE DEPOT, diagnostic tests of pituitary gonadotropic and gonadal functions conducted during treatment and up to three months after discontinuation of LUTRATE DEPOT may be affected.
🔄 Drug / Laboratory Test Interactions ▾
7.1Drug/Laboratory Test Interactions Administration of LUTRATE DEPOT in therapeutic doses results in suppression of the pituitary-gonadal system. Normal function is usually restored within three months after treatment is discontinued. Due to the suppression of the pituitary-gonadal system by LUTRATE DEPOT, diagnostic tests of pituitary gonadotropic and gonadal functions conducted during treatment and up to three months after discontinuation of LUTRATE DEPOT may be affected.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Females and males of reproductive potential: LUTRATE DEPOT may impair fertility. Counsel patients on pregnancy planning and prevention. ( 8.3 ) Pediatric: The use of LUTRATE DEPOT formulations are not indicated for use in children. ( 8.4 ) Geriatric: This label reflects clinical trials for LUTRATE DEPOT in prostate cancer in which the majority of the subjects studied were at least 65 years of age. ( 8.5 )
8.1Pregnancy Risk summary Based on findings in animal studies and mechanism of action, LUTRATE DEPOT may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data in pregnant women to inform the drug-associated risk. In animal developmental and reproductive toxicology studies, administration of a monthly formulation of leuprolide acetate on day 6 of pregnancy (sustained exposure was expected throughout the period of organogenesis) caused adverse embryo-fetal toxicity in animals at doses less than the human dose based on body surface area using an estimated daily dose (see data) .
Advise pregnant patients and females of reproductive potential of the potential risk to the fetus. Animal Data Major fetal malformations were observed in developmental and reproductive toxicology studies in rabbits after a single administration of the monthly formulation of leuprolide acetate on day 6 of pregnancy at doses of 0.00024, 0.0024, and 0.024 mg/kg (approximately 1/1600 to 1/16 the human dose based on body surface area using an estimated daily dose in animals and humans). Since a depot formulation was utilized in the study, a sustained exposure to leuprolide acetate was expected throughout the period of organogenesis and to the end of gestation.
Similar studies in rats did not demonstrate an increase in fetal malformations, however, there was increased fetal mortality and decreased fetal weights with the two higher doses of the monthly formulation of leuprolide acetate in rabbits and with the highest dose (0.024 mg/kg) in rats.
8.2Lactation The safety and efficacy of LUTRATE DEPOT have not been established in females. There is no information regarding the presence of LUTRATE DEPOT in human milk, the effects on the breastfed child, or the effects on milk production. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in a breastfed child from LUTRATE DEPOT, a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
8.3Females and Males of Reproductive Potential Infertility Males Based on findings in animals and mechanism of action, LUTRATE DEPOT may impair fertility in males of reproductive potential [see Nonclinical Toxicology (13.1) ].
8.4Pediatric Use The safety and effectiveness of LUTRATE DEPOT in pediatric patients have not been established.
8.5Geriatric Use In the clinical trials for LUTRATE DEPOT in prostate cancer 74% of the patients studied were at least 65 years of age. Hot flushes occurred with equal frequency in those less than or at least 65 years of age.
🤰 Pregnancy ▾
8.1Pregnancy Risk summary Based on findings in animal studies and mechanism of action, LUTRATE DEPOT may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data in pregnant women to inform the drug-associated risk. In animal developmental and reproductive toxicology studies, administration of a monthly formulation of leuprolide acetate on day 6 of pregnancy (sustained exposure was expected throughout the period of organogenesis) caused adverse embryo-fetal toxicity in animals at doses less than the human dose based on body surface area using an estimated daily dose (see data) .
Advise pregnant patients and females of reproductive potential of the potential risk to the fetus. Animal Data Major fetal malformations were observed in developmental and reproductive toxicology studies in rabbits after a single administration of the monthly formulation of leuprolide acetate on day 6 of pregnancy at doses of 0.00024, 0.0024, and 0.024 mg/kg (approximately 1/1600 to 1/16 the human dose based on body surface area using an estimated daily dose in animals and humans). Since a depot formulation was utilized in the study, a sustained exposure to leuprolide acetate was expected throughout the period of organogenesis and to the end of gestation.
Similar studies in rats did not demonstrate an increase in fetal malformations, however, there was increased fetal mortality and decreased fetal weights with the two higher doses of the monthly formulation of leuprolide acetate in rabbits and with the highest dose (0.024 mg/kg) in rats.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of LUTRATE DEPOT in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use In the clinical trials for LUTRATE DEPOT in prostate cancer 74% of the patients studied were at least 65 years of age. Hot flushes occurred with equal frequency in those less than or at least 65 years of age.
🆘 Overdosage ▾
10 OVERDOSAGE There is no experience of overdosage in clinical trials. In rats, a single subcutaneous dose of 100 mg/kg (approximately 4,000 times the estimated daily human dose based on body surface area), resulted in dyspnea, decreased activity, and excessive scratching. In early clinical trials with daily subcutaneous leuprolide acetate, doses as high as 20 mg/day for up two years caused no adverse effects differing from those observed with the 1 mg/day dose.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Leuprolide acetate, a GnRH agonist, acts as an inhibitor of gonadotropin secretion. Animal studies indicate that following an initial stimulation, continuous administration of leuprolide acetate results in suppression of ovarian and testicular steroidogenesis. This effect was reversible upon discontinuation of drug therapy.
Administration of leuprolide acetate has resulted in inhibition of the growth of certain hormone dependent tumors (prostate tumors in Noble and Dunning male rats and DMBA-induced mammary tumors in female rats) as well as atrophy of the reproductive organs.
12.2Pharmacodynamics In humans, administration of leuprolide acetate results in an initial increase in circulating levels of luteinizing hormone (LH) and follicle stimulating hormone (FSH), leading to a transient increase in levels of the gonadal steroids (testosterone and dihydrotestosterone in males, and estrone and estradiol in premenopausal females). However, continuous administration of leuprolide acetate results in decreased levels of LH and FSH. In males, testosterone is reduced to below castrate threshold.
In premenopausal females, estrogens are reduced to postmenopausal concentrations. These decreases occur within two to four weeks after initiation of treatment. Long-term studies have shown that continuation of therapy with leuprolide acetate maintains testosterone below the castrate level for more than five years.
Leuprolide acetate is not active when given orally.
12.3Pharmacokinetics Absorption Following two sequential injections of LUTRATE DEPOT 22.5 mg administered with a 3-month interval, plasma leuprolide acetate concentrations were similar among both cycles. After first administration, mean plasma leuprolide concentration of 46.8 ng/mL was observed at approximately 2 hours and the mean concentration then declined until next injection. Distribution The mean steady-state volume of distribution of leuprolide acetate following intravenous bolus administration to healthy male volunteers was 27 L.
In vitro binding to human plasma proteins ranged from 43% to 49%. Elimination The mean systemic clearance of leuprolide acetate following intravenous bolus administration to healthy male volunteers was
7.6L/h, and terminal elimination half-life was approximately 3 hours based on a two-compartment model. Upon administration with different leuprolide acetate formulations, the major metabolite of leuprolide acetate is a pentapeptide (M- 1) metabolite.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Leuprolide acetate, a GnRH agonist, acts as an inhibitor of gonadotropin secretion. Animal studies indicate that following an initial stimulation, continuous administration of leuprolide acetate results in suppression of ovarian and testicular steroidogenesis. This effect was reversible upon discontinuation of drug therapy.
Administration of leuprolide acetate has resulted in inhibition of the growth of certain hormone dependent tumors (prostate tumors in Noble and Dunning male rats and DMBA-induced mammary tumors in female rats) as well as atrophy of the reproductive organs.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING LUTRATE ® DEPOT is supplied as a kit consisting of a LEUPROLIDE ACETATE MIXJECT single-dose delivery system consisting of a vial with a Flip-Off seal containing sterile, white to off white lyophilized leuprolide acetate microspheres incorporated in a biodegradable polymer, a MIXJECT vial adapter containing the needle, and a pre-filled syringe containing clear sterile mannitol solution for injection, USP, 2 mL, pH 4.5 to 7.0. LUTRATE ® DEPOT (leuprolide acetate for depot suspension) 22.5 mg – NDC 83831-134-01 Storage Store at controlled room temperature at 20°-25°C (68°-77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [ see USP Controlled Room Temperature ].
📋 Description ▾
11 DESCRIPTION Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula: Where: n=1 or 2 Leuprolide acetate has a molecular weight of 1209.41 as "free base”.
Leuprolide is freely soluble in water. LUTRATE DEPOT 22.5 mg for 3-month administration is available in a vial containing white to off white sterile lyophilized microspheres together with the corresponding sterile reconstitution diluent in a pre-filled syringe. When LUTRATE DEPOT and the diluent are mixed together they become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS as a single dose.
Each vial of LUTRATE DEPOT 22.5 mg for 3-month administration delivers leuprolide acetate (22.5 mg), polylactic acid (188.4 mg), triethylcitrate (10.4 mg), polysorbate 80 (3.8 mg), mannitol (88.4 mg) and carmellose sodium (25 mg). The prefilled syringe containing the clear reconstitution diluent (2 mL) contains mannitol (16 mg), water for injection, and sodium hydroxide and hydrochloric acid to control pH. LUTRATE DEPOT is an extended release sterile, single dose injection in suspension form for intramuscular administration.
Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Hypersensitivity Inform patients that if they have experienced hypersensitivity with other GnRH agonist drugs like LUTRATE DEPOT, LUTRATE DEPOT is contraindicated [ see Contraindications (4) ]. Tumor Flare Inform patients that LUTRATE DEPOT can cause tumor flare during the first weeks of treatment. Inform patients that the increase in testosterone can cause an increase in urinary symptoms or pain.
Advise patients to contact their healthcare provider if ureteral obstruction, spinal cord compression, paralysis, or new or worsened symptoms occur after beginning LUTRATE DEPOT treatment [ s ee Warnings and Precautions (5.1) ]. Metabolic Syndrome Advise patients that there is an increased risk of metabolic changes such as hyperglycemia, diabetes, hyperlipidemia, and non-alcoholic fatty liver disease with LUTRATE DEPOT therapy. Inform patients that periodic monitoring for metabolic changes is required when being treated with LUTRATE DEPOT [ see Warnings and Precautions (5.2) ].
Cardiovascular Disease Inform patients that there is an increased risk of myocardial infarction, sudden cardiac death, and stroke with LUTRATE DEPOT treatment. Advise patients to immediately report signs and symptoms associated with these events to their healthcare provider for evaluation [see Warnings and Precautions (5.3) ]. Severe Cutaneous Adverse Reactions Inform patients that severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), which may be life threating or fatal, may occur during treatment with LUTRATE DEPOT.
Advice patients to contact their healthcare provider or seek medical attention right away if they experience signs or symptoms of SCARs [see Warnings and Precautions (5.6) ] . Urogenital Disorders Advise patients that LUTRATE DEPOT may cause impotence [see Use In Specific Populations (8.3) ] . Infertility Inform patients that LUTRATE DEPOT may cause infertility [see Use In Specific Populations (8.3 )].
Continuation of LUTRATE DEPOT Treatment Inform patients that LUTRATE DEPOT is usually continued, often with additional medication, after the development of metastatic castration-resistant prostate cancer [see Dosage and Administration (2.1) ]. Trademarks are property of their respective owners and are not of Avyxa Pharma, LLC For more information or a video demonstration on how to use, scan the code below or call 1-888-520-0954. Manufactured for: Avyxa Pharma, LLC New Jersey 07054, USA Made in Spain 99356473 qrcode
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Absorption Following two sequential injections of LUTRATE DEPOT 22.5 mg administered with a 3-month interval, plasma leuprolide acetate concentrations were similar among both cycles. After first administration, mean plasma leuprolide concentration of 46.8 ng/mL was observed at approximately 2 hours and the mean concentration then declined until next injection. Distribution The mean steady-state volume of distribution of leuprolide acetate following intravenous bolus administration to healthy male volunteers was 27 L.
In vitro binding to human plasma proteins ranged from 43% to 49%. Elimination The mean systemic clearance of leuprolide acetate following intravenous bolus administration to healthy male volunteers was
7.6L/h, and terminal elimination half-life was approximately 3 hours based on a two-compartment model. Upon administration with different leuprolide acetate formulations, the major metabolite of leuprolide acetate is a pentapeptide (M- 1) metabolite.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics In humans, administration of leuprolide acetate results in an initial increase in circulating levels of luteinizing hormone (LH) and follicle stimulating hormone (FSH), leading to a transient increase in levels of the gonadal steroids (testosterone and dihydrotestosterone in males, and estrone and estradiol in premenopausal females). However, continuous administration of leuprolide acetate results in decreased levels of LH and FSH. In males, testosterone is reduced to below castrate threshold.
In premenopausal females, estrogens are reduced to postmenopausal concentrations. These decreases occur within two to four weeks after initiation of treatment. Long-term studies have shown that continuation of therapy with leuprolide acetate maintains testosterone below the castrate level for more than five years.
Leuprolide acetate is not active when given orally.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1LUTRATE DEPOT 22.5 mg for 3-Month Administration The efficacy of LUTRATE DEPOT 22.5 mg was evaluated in an open-label, multicenter, non-controlled, multiple dose clinical trial which enrolled 162 evaluable patients with prostate cancer. Patients were administered LUTRATE DEPOT 22.5 mg intramuscularly in 2 doses (157 received 2 injections) with a 3-month interval. The median age was 71 years (range; 47-91), 62% White, and 30% Black or African-American.
Castrate levels of serum testosterone (<50 ng/dL) were achieved and maintained from Day 28 to 168 in 94.3% (95% CI:89.4, 97.0) of patients. On Day 28, 160 of the 162 (98.8%) patients had castrate testosterone levels. One patient did not achieve a castrate level and one had a missing value.
Testosterone escapes (any value > 50 ng/dL after castrate levels were achieved) occurred in four patients. In addition, three patients had a single unevaluable testosterone level after Day 28 that was considered to be non-castrate in this analysis. Figure 1.
Mean testosterone plasma levels during treatment with two three-month IM injections of LUTRATE DEPOT 22.5 mg Figure 1
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Two-year carcinogenicity studies were conducted with leuprolide acetate in rats and mice. In rats, a dose-related increase of benign pituitary hyperplasia and benign pituitary adenomas was noted at 24 months when the drug was administered subcutaneously at high daily doses (0.6 to 4 mg/kg). There was a significant but not dose-related increase of pancreatic islet cell adenomas in females and of testicular interstitial cell adenomas in males (highest incidence in the low dose group).
In mice, no leuprolide acetate-induced tumors or pituitary abnormalities were observed at a dose as high as 60 mg/kg for two years. Patients have been treated with leuprolide acetate for up to three years with doses as high as 10 mg/day and for two years with doses as high as 20 mg/day without demonstrable pituitary abnormalities. No carcinogenicity studies have been conducted with LUTRATE DEPOT.
Genotoxicity studies were conducted with leuprolide acetate using bacterial and mammalian systems. These studies provided no evidence of mutagenic effects or chromosomal aberrations. Leuprolide acetate may reduce male and female fertility.
Administration of leuprolide acetate to male and female rats at dose of 0.024, 0.24, and 2.4 mg/kg as monthly depot formulation for up to 3 months (approximately as low as 1/30 of the human dose based on body surface area using an estimated daily dose in animals and humans) caused atrophy of the reproductive organs, and suppression of reproductive function. These changes were reversible upon cessation of treatment.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Two-year carcinogenicity studies were conducted with leuprolide acetate in rats and mice. In rats, a dose-related increase of benign pituitary hyperplasia and benign pituitary adenomas was noted at 24 months when the drug was administered subcutaneously at high daily doses (0.6 to 4 mg/kg). There was a significant but not dose-related increase of pancreatic islet cell adenomas in females and of testicular interstitial cell adenomas in males (highest incidence in the low dose group).
In mice, no leuprolide acetate-induced tumors or pituitary abnormalities were observed at a dose as high as 60 mg/kg for two years. Patients have been treated with leuprolide acetate for up to three years with doses as high as 10 mg/day and for two years with doses as high as 20 mg/day without demonstrable pituitary abnormalities. No carcinogenicity studies have been conducted with LUTRATE DEPOT.
Genotoxicity studies were conducted with leuprolide acetate using bacterial and mammalian systems. These studies provided no evidence of mutagenic effects or chromosomal aberrations. Leuprolide acetate may reduce male and female fertility.
Administration of leuprolide acetate to male and female rats at dose of 0.024, 0.24, and 2.4 mg/kg as monthly depot formulation for up to 3 months (approximately as low as 1/30 of the human dose based on body surface area using an estimated daily dose in animals and humans) caused atrophy of the reproductive organs, and suppression of reproductive function. These changes were reversible upon cessation of treatment.
📚 References ▾
15 REFERENCES 1. “OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html
📄 Recent Major Changes ▾
Warnings and Precautions ( 5.6 ) 11/2024
📄 Package Label / Principal Display Panel ▾
NDC 83831-134-01 Rx Only Lutrate ® Depot (Leuprolide acetate for depot suspension) 22.5 mg For intramuscular injection See package insert for reconstitution and administration procedures Recommended dose: one intramuscular injection every three months Sterile Must be reconstituted before use AVYXA Carton
Medicare Part D spend CMS · PART D · 2026 (Q1)
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